pharmacopeia
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Mechanism of action

Sourced from openFDA

Delgocitinib, a Janus kinase (JAK) inhibitor, inhibits the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2). JAK signaling involves recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors, and activation and subsequent localization of STATs to the nucleus, leading to the expression of cytokine-responsive genes to induce specific biological responses in target cells.

Janus KinaseJanus Kinase 3Tyrosine Kinase 2

Indications

Sourced from openFDA
  • ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. ANZUPGO is a Janus kinase (JAK) inhibitor indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.

Contraindications

Sourced from openFDA
  • None None.contraindicated

Dosage & administration

Sourced from openFDA

See the full prescribing information for recommended immunizations prior to treatment. ( 2.1 ) Do not use more than 30 grams per 2 weeks or 60 grams per month. Apply twice daily to skin of the affected areas only on the hands and wrists. ( 2.2 ) For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2.2 ) 2.1 Recommended Immunizations Prior to Treatment Initiation Complete any necessary immunizations, including herpes zoster vaccinations, according to current immunization guidelines prior to ANZUPGO treatment [see Warnings and Precautions (5.3) ]. 2.2 Recommended Dosage and Administration Do not use more than 30 grams per 2 weeks or 60 grams per month. Prior to applying ANZUPGO, clean and dry affected areas. Apply a thin layer of ANZUPGO, twice daily, to the affected areas only on the hands and wrists. ANZUPGO is for topical use only. Not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.

Warnings & precautions

Sourced from openFDA

Serious Infections: ANZUPGO may increase the risk of infection. Eczema herpeticum was observed in a subject treated topically with ANZUPGO. Avoid use of ANZUPGO in patients with an active or serious infection. If a serious infection develops, discontinue ANZUPGO until the infection resolves. ( 5.1 ) Non-melanoma Skin Cancers: Non-melanoma skin cancers including basal cell carcinoma have been reported in subjects treated with ANZUPGO. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. ( 5.2 ) Immunizations: Avoid vaccination with live vaccines immediately prior to, during, and immediately after ANZUPGO treatment. ( 5.3 ) Potential Risks Related to JAK Inhibition: It is not known whether ANZUPGO may be associated with the observed or potential adverse reactions of JAK inhibition. Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis (RA) patients. ANZUPGO is not approved for use in RA. Treatment with oral and topical JAK inhibitors has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. ( 5.4 ) 5.1 Serious Infections ANZUPGO may increase the risk of infections.

Adverse reactions

Sourced from openFDA

Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ANZUPGO was evaluated in two randomized, double-blind, multicenter, vehicle-controlled clinical trials (TRIAL 1 and TRIAL 2), in which 959 adults with moderate to severe CHE received ANZUPGO or vehicle cream topically twice daily for 16 weeks. A total of 638 subjects were treated with ANZUPGO [see Clinical Studies (14) ] . In TRIAL 1 and TRIAL 2, adverse reactions that were reported in ≤ 1% of subjects in the ANZUPGO group were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. In an open label extension trial (TRIAL 3), 801 subjects were treated for up to an additional 36 weeks after completing TRIAL 1 or TRIAL 2. A total of 198 subjects received continuous treatment with ANZUPGO for 52 weeks.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary The available data on the use of topical delgocitinib during pregnancy is insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of delgocitinib to pregnant rats and rabbits during the period of organogenesis did not result in adverse developmental effects at doses 120 or 193 times, respectively, the maximum recommended human dose (MRHD) based on AUC comparison (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In embryofetal development studies, delgocitinib was administered orally to pregnant rats or rabbits during the period of organogenesis at doses of 3, 10 and 30 mg/kg/day in rats, and 1, 3 and 10 mg/kg/day in rabbits, respectively. In rats, no significant maternal toxicity was noted at doses up to 30 mg/kg/day (1446 times the MRHD based on AUC comparison).

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of ANZUPGO were evaluated in a pharmacokinetic (PK) trial involving 15 adult subjects 22 to 69 years of age with moderate to severe CHE and in 313 subjects in TRIAL 2 [see Clinical Studies (14) ]. Absorption In the PK trial, subjects applied on average 0.87 g of ANZUPGO topically to the affected areas of the hands and wrists twice a day for 8 days.

Approval history

Sourced from openFDA
  • Jul 23, 2025NDANDA219155Leo Pharma As

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
179 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Product Use In Unapproved Indication4223%
  2. 2Pruritus1911%
  3. 3Dermatitis147.8%
  4. 4Erythema147.8%
  5. 5Dermatitis Atopic126.7%
  6. 6Drug Ineffective126.7%
  7. 7Rash95.0%
  8. 8Erythema Multiforme84.5%
  9. 9Dry Skin63.4%
  10. 10Skin Burning Sensation63.4%
  11. 11Burning Sensation52.8%
  12. 12Cellulitis52.8%
  13. 13Off Label Use52.8%
  14. 14Condition Aggravated42.2%
  15. 15Drug Ineffective For Unapproved Indication42.2%

Clinical trials

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The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Delgocitinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Delgocitinib work?
Delgocitinib, a Janus kinase (JAK) inhibitor, inhibits the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2). JAK signaling involves recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors, and activation and subsequent localization of STATs to the nucleus, leading to the expression of cytokine-responsive genes to induce specific biological responses in target cells.
What is Delgocitinib used for?
According to FDA labeling, Delgocitinib carries indications including: ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. ANZUPGO is a Janus kinase (JAK) inhibitor indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Delgocitinib?
Delgocitinib is classified as Agents for dermatitis, excluding corticosteroids, Janus Kinase Inhibitor, Janus Kinase 3 Inhibitors, Janus Kinase Inhibitors, Tyrosine Kinase 2 Inhibitors, Decreased Cytokine Activity.
What are the brand names for Delgocitinib?
Delgocitinib is marketed under brand names including Anzupgo.
What are the contraindications for Delgocitinib?
Delgocitinib labeling lists contraindications including: None None.. Always consult the full prescribing information and a clinician.
Note. Data for delgocitinib is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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